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NCT00074490 · STUDY IN CONTEXT

Donor Stem Cell Transplant With No or Low-Intensity Chemotherapy Using Sirolimus and Treated Immune Cells to Treat Blood and Lymph Cancers

Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

T cells administered by intravenous infusion after patient received transplant.

Source null

→

primary · POSTED

GVHD of the skin, liver and gut were graded on a scale of 1, 2, 3, and 4 (e.g. the grades are not added together) using the National Institutes of Health Consensus Criteria. Grade 1 is minimal GVHD, Grade 2 is moderate GVHD, Grade 3 is severe GVHD and Grade 4 is very severe GVHD. Grade 4 is a worse outcome than Grade 1.

Source null

→

secondary · POSTED

Detection of cytokine secretion was done by enzyme-linked immunosorbent assay.

This outcome measure was not done. Data was not collected for this outcome measure due to premature closure of study.

→

secondary · POSTED

Participants are susceptible to opportunistic infections such as bacterial, fungal, viral, protozoan infections and more due to immune suppression from chemotherapy drugs used to treat their disease.

Source null

→

secondary · POSTED

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Source null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes-refractory-a84ec8fd
nct id
NCT00074490
trial label
Donor Stem Cell Transplant With No or Low-Intensity Chemotherapy Using Sirolimus and Treated Immune Cells to Treat Blood and Lymph Cancers
applicability
unclear
applicability note
Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
5
harms Count
5
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00074490
    outcome key
    om-0000
    source section id
    NCT00074490-om-0000
    source outcome index
    0
    endpoint
    Percentage of Patients to Receive T Cell Infusion
    endpoint definition
    T cells administered by intravenous infusion after patient received transplant.
    time origin
    first 100 days post-transplant
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00074490
    outcome key
    om-0001
    source section id
    NCT00074490-om-0001
    source outcome index
    1
    endpoint
    Percentage of Patients With ≥ Grade 2 Acute Graft Versus Host Disease (GVHD)
    endpoint definition
    GVHD of the skin, liver and gut were graded on a scale of 1, 2, 3, and 4 (e.g. the grades are not added together) using the National Institutes of Health Consensus Criteria. Grade 1 is minimal GVHD, Grade 2 is moderate GVHD, Grade 3 is severe GVHD and Grade 4 is very severe GVHD. Grade 4 is a worse outcome than Grade 1.
    time origin
    first 100 days post-transplant
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00074490
    outcome key
    om-0002
    source section id
    NCT00074490-om-0002
    source outcome index
    2
    endpoint
    Detection of of Post-transplantation Cluster of Differentiation 4 (CD4)+ and CD8+ T-cell Production of T Helper 1 -2 (Th1-Th2)-Type Cytokines
    endpoint definition
    Detection of cytokine secretion was done by enzyme-linked immunosorbent assay.
    time origin
    First 100 days post-transplant
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    This outcome measure was not done. Data was not collected for this outcome measure due to premature closure of study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00074490
    outcome key
    om-0003
    source section id
    NCT00074490-om-0003
    source outcome index
    3
    endpoint
    Percentage of Patients With Opportunistic Infection
    endpoint definition
    Participants are susceptible to opportunistic infections such as bacterial, fungal, viral, protozoan infections and more due to immune suppression from chemotherapy drugs used to treat their disease.
    time origin
    First 100 days post-transplant
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00074490
    outcome key
    om-0004
    source section id
    NCT00074490-om-0004
    source outcome index
    4
    endpoint
    Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0)
    endpoint definition
    Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
    time origin
    Date treatment consent signed to date off study, approximately 5 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00074490
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm IVD Cohort 1 (Th2 DLI)
    regimen
    Patients receive low intensity fludarabine phosphate intravenous (IV) and cyclophosphamide IV on days -6 to -3. Patients undergo donor lymphocyte infusion (DLI) with sirolimus generated donor T-helper 2 (Th2) cells on day 14 (single T-Rapa cell DLI in patients with cluster of differentiation 4 (CD4) count between 100 and 200 inclusive).
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00074490-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00074490
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm IVD Cohort 3 (Multiple Th2 DLI)
    regimen
    Patients with nonlymphoma diagnosis or rapidly progressive lymphoma undergo DLI with multiple infusions of sirolimus generated donor Th2 cells beginning on day 14 (multiple T-Rapa cell DLI in patients with CD4 count lower than 100 or ALC lower than 300).
    analyzed count
    27
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00074490-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00074490
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Arm IVA (12-day Expanded Th2 DLI)
    regimen
    Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine by mouth twice a day (PO BID) on days -4 to 100, and standard dose sirolimus PO on days -2 to 14. Patients undergo mobilized allogeneic peripheral blood stem cells (PBSC) on day 0. Patients undergo DLI with 12-day expanded sirolimus-generated donor Th2 cells on day 14.
    analyzed count
    40
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00074490-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00074490
    outcome key
    om-0000
    arm key
    OG003
    arm label
    Arm IVB (6-day Expanded Th2 DLI)
    regimen
    Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine PO BID on days -4 to 100, and standard dose sirolimus PO on days -2 to 14. Patients undergo mobilized allogeneic PBSC or bone marrow transplant on day 0. Patients undergo DLI with 6-day expanded sirolimus-generated donor Th2 cells on day 14.
    analyzed count
    44
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00074490-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00074490
    outcome key
    om-0000
    arm key
    OG004
    arm label
    Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus)
    regimen
    Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine PO BID on days -7 to 100 and high dose sirolimus PO on days -4 to 7, Patients undergo mobilized allogeneic PBSC on day 0. Patients undergo DLI with 6-day expanded sirolimus-generated donor Th2 cells on day 14.
    analyzed count
    42
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00074490-om-0000#groups/OG004
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00074490
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm IVD Cohort 1 (Th2 DLI)
    regimen
    Patients receive low intensity fludarabine phosphate intravenous (IV) and cyclophosphamide IV on days -6 to -3. Patients undergo donor lymphocyte infusion (DLI) with sirolimus generated donor T-helper 2 (Th2) cells on day 14 (single T-Rapa cell DLI in patients with cluster of differentiation 4 (CD4) count between 100 and 200 inclusive).
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00074490-om-0001#groups/OG000
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00074490
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Arm IVD Cohort 3 (Multiple Th2 DLI)
    regimen
    Patients with nonlymphoma diagnosis or rapidly progressive lymphoma undergo DLI with multiple infusions of sirolimus generated donor Th2 cells beginning on day 14 (multiple T-Rapa cell DLI in patients with CD4 count lower than 100 or ALC lower than 300).
    analyzed count
    27
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00074490-om-0001#groups/OG001
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00074490
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Arm IVA (12-day Expanded Th2 DLI)
    regimen
    Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine by mouth twice a day (PO BID) on days -4 to 100, and standard dose sirolimus PO on days -2 to 14. Patients undergo mobilized allogeneic peripheral blood stem cells (PBSC) on day 0. Patients undergo DLI with 12-day expanded sirolimus-generated donor Th2 cells on day 14.
    analyzed count
    40
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00074490-om-0001#groups/OG002
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00074490
    outcome key
    om-0001
    arm key
    OG003
    arm label
    Arm IVB (6-day Expanded Th2 DLI)
    regimen
    Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine PO BID on days -4 to 100, and standard dose sirolimus PO on days -2 to 14. Patients undergo mobilized allogeneic PBSC or bone marrow transplant on day 0. Patients undergo DLI with 6-day expanded sirolimus-generated donor Th2 cells on day 14.
    analyzed count
    44
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00074490-om-0001#groups/OG003
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00074490
    outcome key
    om-0001
    arm key
    OG004
    arm label
    Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus)
    regimen
    Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine PO BID on days -7 to 100 and high dose sirolimus PO on days -4 to 7, Patients undergo mobilized allogeneic PBSC on day 0. Patients undergo DLI with 6-day expanded sirolimus-generated donor Th2 cells on day 14.
    analyzed count
    42
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00074490-om-0001#groups/OG004
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00074490
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm IVD Cohort 1 (Th2 DLI)
    regimen
    Patients receive low intensity fludarabine phosphate intravenous (IV) and cyclophosphamide IV on days -6 to -3. Patients undergo donor lymphocyte infusion (DLI) with sirolimus generated donor T-helper 2 (Th2) cells on day 14 (single T-Rapa cell DLI in patients with cluster of differentiation 4 (CD4) count between 100 and 200 inclusive).
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00074490-om-0002#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00074490
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Arm IVD Cohort 3 (Multiple Th2 DLI)
    regimen
    Patients with nonlymphoma diagnosis or rapidly progressive lymphoma undergo DLI with multiple infusions of sirolimus generated donor Th2 cells beginning on day 14 (multiple T-Rapa cell DLI in patients with CD4 count lower than 100 or ALC lower than 300).
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00074490-om-0002#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00074490
    harm key
    EG000
    source section id
    NCT00074490-ae
    event group key
    EG000
    event group label
    Arm IVD Cohort 1 (Th2 DLI)
    serious affected
    1
    serious at risk
    1
    other affected
    1
    other at risk
    1
    frequency threshold
    0
    collection period
    Date treatment consent signed to date off study, approximately 5 years.
    event definition
    Enrollment was 442 (221 donors; 221 patients). No data was collected from the donor population. 57 recipients were treated on cohorts no longer in the protocol due to amendments. Thus, 164 of 221 recipient data is presented. No patients were eligible for therapy on arm IVD, cohort 2.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00074490
    harm key
    EG001
    source section id
    NCT00074490-ae
    event group key
    EG001
    event group label
    Arm IVD Cohort 3 (Multiple Th2 DLI)
    serious affected
    22
    serious at risk
    34
    other affected
    28
    other at risk
    34
    frequency threshold
    0
    collection period
    Date treatment consent signed to date off study, approximately 5 years.
    event definition
    Enrollment was 442 (221 donors; 221 patients). No data was collected from the donor population. 57 recipients were treated on cohorts no longer in the protocol due to amendments. Thus, 164 of 221 recipient data is presented. No patients were eligible for therapy on arm IVD, cohort 2.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00074490
    harm key
    EG002
    source section id
    NCT00074490-ae
    event group key
    EG002
    event group label
    Arm IVA (12-day Expanded Th2 DLI)
    serious affected
    37
    serious at risk
    40
    other affected
    40
    other at risk
    40
    frequency threshold
    0
    collection period
    Date treatment consent signed to date off study, approximately 5 years.
    event definition
    Enrollment was 442 (221 donors; 221 patients). No data was collected from the donor population. 57 recipients were treated on cohorts no longer in the protocol due to amendments. Thus, 164 of 221 recipient data is presented. No patients were eligible for therapy on arm IVD, cohort 2.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00074490
    harm key
    EG003
    source section id
    NCT00074490-ae
    event group key
    EG003
    event group label
    Arm IVB (6-day Expanded Th2 DLI)
    serious affected
    35
    serious at risk
    44
    other affected
    38
    other at risk
    44
    frequency threshold
    0
    collection period
    Date treatment consent signed to date off study, approximately 5 years.
    event definition
    Enrollment was 442 (221 donors; 221 patients). No data was collected from the donor population. 57 recipients were treated on cohorts no longer in the protocol due to amendments. Thus, 164 of 221 recipient data is presented. No patients were eligible for therapy on arm IVD, cohort 2.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00074490
    harm key
    EG004
    source section id
    NCT00074490-ae
    event group key
    EG004
    event group label
    Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus)
    serious affected
    31
    serious at risk
    45
    other affected
    36
    other at risk
    45
    frequency threshold
    0
    collection period
    Date treatment consent signed to date off study, approximately 5 years.
    event definition
    Enrollment was 442 (221 donors; 221 patients). No data was collected from the donor population. 57 recipients were treated on cohorts no longer in the protocol due to amendments. Thus, 164 of 221 recipient data is presented. No patients were eligible for therapy on arm IVD, cohort 2.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice